Dictionary of Pharmaceutical Medicine by Dr. med. Dr. phil. Gerhard Nahler (auth.)

By Dr. med. Dr. phil. Gerhard Nahler (auth.)

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Efficacy Therapeutic or pharmacological result of a DRUG or treatment in a controlled clinical situation; assessment of e. needs (EC): "specification of the effect parameters to be used, description of howe. are measured and recorded, times and periods of e. ) "; see also EFFECT, EFFECTIVENESS. elderly Subjects older than 65 years; see GERIATRIC EVALUATIONS, HEALTH CARE COSTS . eligibility checklist Contains detailed questions which establish a patient's e. g. demographic informations, confirmation of DISEASE (INCL USION CRIT ERIA) , lab values, performance status, EXCL USION CRITERIA, date of signed INFORMED CONSENT, etc.

G. also impor tan t know-how concerning th e individual steps of th e man ufactur ing method such as reaction co nd itions, temperature, validation and evaluatio n data for certain cri tical steps of the manufacturing method, and on quality control during manufacture. drug monitoring (1) co nt inuous measurements of drug concentrations in biological fluid s or tissues for th erapeutic or safety reasons; (2) see POST-MARKETING SURVEILlANCE. g. ) that contains an active drug ingredient gen erally, but no t necessaril y, in associatio n with inac tive ingred ien ts; see also FORMULAT ION.

Drug ex perience re port Report on an ADVERSE REACTIO N; see also REPORT . 000 to fataliti es; women are more oft en affec ted than men and older pa tients more oft en th an you nge r subjec ts; see ADVERSE REACTIO N. g. also impor tan t know-how concerning th e individual steps of th e man ufactur ing method such as reaction co nd itions, temperature, validation and evaluatio n data for certain cri tical steps of the manufacturing method, and on quality control during manufacture. drug monitoring (1) co nt inuous measurements of drug concentrations in biological fluid s or tissues for th erapeutic or safety reasons; (2) see POST-MARKETING SURVEILlANCE.

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